Cleared Traditional

K043587 - SUCRALFATE AND CARAFATE PASTE KITS

K043587 · Patrick D. Mcgrath Ph.D · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
402d
Days
-
Risk

K043587 is an FDA 510(k) clearance for the SUCRALFATE AND CARAFATE PASTE KITS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Patrick D. Mcgrath Ph.D (Gurnee, US). The FDA issued a Cleared decision on February 3, 2006 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K043587

510(k) Number K043587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2004
Decision Date February 03, 2006
Days to Decision 402 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
287d slower than avg
Panel avg: 115d · This submission: 402d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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K043587 · SUCRALFATE AND CARAFATE PASTE KITS
Download PDF FDA Summary Patrick D. Mcgrath Ph…